Comparison of Early Results of Mobile and Fixed Insert Unicondylar Knee Prosthesis.

Sponsor

Bezmialem Vakif University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05094258

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of the early clinical and radiological results and patient satisfaction of the mobile and fixed insert unicondylar knee prostheses routinely used in the clinic.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Procedure: unicondylar knee prosthesis with mobile insert Procedure: unicondylar knee prosthesis with fixed insert	N/A

Detailed Description

Unicondylar knee prosthesis operation will be performed on patients with unicompartmental knee arthrosis who apply to our clinic. Patients will be randomized to use mobile or fixed inserts. After 1 year of follow-up, SF-36, KOOS and HSS scores will be taken to examine the clinical satisfaction of the patients. In addition, radiological evaluation will be made for the presence of osteolysis at the tibial implant interface between both groups.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients with medial knee arthrosis will be randomized to receive unicompartmental knee prosthesis using mobile inserts in 30 patients and fixed inserts in 30 patients. Patients will be evaluated after at least 1 year of follow-upPatients with medial knee arthrosis will be randomized to receive unicompartmental knee prosthesis using mobile inserts in 30 patients and fixed inserts in 30 patients. Patients will be evaluated after at least 1 year of follow-up

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

After collecting all data about patients and patients participating in the study, the independent person who will evaluate the data will be blinded.

Primary Purpose:

Treatment

Official Title:

Comparison of Early Clinical and Radiological Results and Patient Satisfaction of Mobile and Fixed Insert Unicondylar Knee Prosthesis

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: mobile insert Unicondylar knee arthroplasty with mobile insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.	Procedure: unicondylar knee prosthesis with mobile insert Patients with unicondylar knee replacement using the mobile insert option
Active Comparator: fixed insert Unicondylar knee arthroplasty with fixed insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.	Procedure: unicondylar knee prosthesis with fixed insert Patients with unicondylar knee replacement using the fixed insert option

Arm

Intervention/Treatment

Active Comparator: mobile insert

Unicondylar knee arthroplasty with mobile insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.

Procedure: unicondylar knee prosthesis with mobile insert

Patients with unicondylar knee replacement using the mobile insert option

Active Comparator: fixed insert

Unicondylar knee arthroplasty with fixed insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.

Procedure: unicondylar knee prosthesis with fixed insert

Patients with unicondylar knee replacement using the fixed insert option

Outcome Measures

Primary Outcome Measures

Short Form Health Survey (SF-36) [0-1 year]
SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year
Knee injury and osteoarthritis outcome score (KOOS) [0-1 year]
Knee injury and osteoarthritis outcome score (0-100)

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with degenerative knee arthritis with only one compartment affected

Exclusion Criteria:

Inflammatory Arthritis
Tricompartmental arthritis
Patients with fixed varus deformity greater than -10 degrees
Patients with fixed valgus deformity greater than -5 degrees
Patients with knee range of motion less than 90 degrees
Patients with more than 10 degrees of flexion contracture"

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Volkan Ezici	Istanbul	Fatih	Turkey	3344

Sponsors and Collaborators

Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Murat Sarikas, orthopaedic surgeon, Bezmialem Vakif University

ClinicalTrials.gov Identifier:

NCT05094258

Other Study ID Numbers:

61813471876

First Posted:

Oct 26, 2021

Last Update Posted:

Nov 30, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Murat Sarikas, orthopaedic surgeon, Bezmialem Vakif University

Unicompartmental Knee osteoarthritis

Unicompartmental Knee prosthesis

Mobile insert

Fixed İnsert

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 30, 2021